FDA recall Z-1297-2023

Entopsis , Inc. · Class II · device

Product

PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples

Reason for recall

Presence of misleading label statements on the product label.

Distribution

Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania

Key facts

Status
Ongoing
Initiation date
2023-02-21
Report date
2023-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Medley, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1297-2023